Archive for September 2018

The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert Friday and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products. Source: Drug Industry Daily

Several leading drugmakers — including Janssen, Novo Nordisk and Genentech — urged the FDA to include new information on interchangeable products in the agency’s Purple Book, which lists biological products including biosimilars and interchangeables licensed by the agency. Source: Drug Industry Daily

In new draft guidance issued Friday, the FDA outlined what it expects sponsors to include in submissions of use-related risk analyses, threshold analyses, comparative use human factors (HF) and HF validation study protocols and reports. Source: Drug Industry Daily

The FDA Friday issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and get treatments to market more swiftly and efficiently. Source: Drug Industry Daily

A newly unsealed lawsuit accuses AstraZeneca of using nurses to covertly promote its products, echoing a similar complaint against AbbVie. Source: Drug Industry Daily

Mylan and Novartis criticized the FDA’s use of arbitrary suffixes in a non-proprietary naming convention for biologics in comments about a Sept. 4 a public hearing aimed at promoting biosimilars and interchangeable products. Source: Drug Industry Daily

White House-backed measures to prohibit pharmacy “gag clauses” are poised to become law after the House unanimously approved them Tuesday. Source: Drug Industry Daily

Symed Labs was hit with a Form 483 after an FDA inspection of its Hyderabad, Telangana facility revealed equipment cleaning and complaint handling violations. Source: Drug Industry Daily

The FDA slapped Phoenix-based outsourcing facility Atlas Pharmaceuticals with a warning letter for adulterated and misbranded drug products as well as numerous CGMP violations stemming from an inspection carried out in August and September 2017. Source: Drug Industry Daily

Prices increased for 4,400 branded drugs and were cut for only 50 this year, a new study found. Source: Drug Industry Daily